Dosing underway for Phase 1 monotherapy study
of NUV-868 in advanced solid tumors
Strong financial position provides cash runway
through 2028; cash, cash equivalents and marketable securities of
$703.8 million as of June 30, 2022
Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company
tackling some of the greatest unmet needs in oncology by developing
differentiated and novel therapeutic candidates, today reported its
financial results for the second quarter ended June 30, 2022, and
provided a business update.
“We are committed to advancing innovative therapies as quickly
and safely as possible for people with cancers that do not
currently have adequate treatment options. As previously announced,
this commitment has led us to re-prioritize our pipeline and focus
on our BET inhibitor, NUV-868, which is progressing in an ongoing
Phase 1 study, and our novel small molecule DDC platform,” said
David Hung, M.D., Founder, President and Chief Executive Officer of
Nuvation Bio. “With $703.8 million in cash, cash equivalents and
marketable securities as of June 30, 2022, and our experienced team
— including our new Chief Medical Officer, David Liu, M.D., Ph.D.,
and our new Chief Regulatory Officer, Kerry Wentworth — we are well
positioned to advance our programs for the benefit of patients and
our stakeholders.”
Recent Business Updates
NUV-868, BD2-Selective BETi: Advanced solid tumors
- Dosing underway in the Phase 1 monotherapy study of
NUV-868. The recently initiated Phase 1 study in advanced solid
tumors, including ovarian, pancreatic, metastatic
castration-resistant prostate and triple negative breast cancers,
is designed to determine the safety and dose of NUV-868 to be used
as a monotherapy and in combination with olaparib or enzalutamide
for the Phase 2 and Phase 2b portions of the study.
Corporate Updates
- Strengthened executive management team. The Company
appointed David Liu, M.D., Ph.D., as Chief Medical Officer in July
2022, and Kerry Wentworth as Chief Regulatory Officer in May 2022.
Both leaders are also part of the Executive Committee.
Second Quarter 2022 Financial Results
As of June 30, 2022, Nuvation Bio had cash, cash equivalents and
marketable securities of $703.8 million.
For the three months ended June 30, 2022, research and
development expenses were $28.9 million, compared to $14.0 million
for the three months ended June 30, 2021. The increase was
primarily due to a $12.3 million increase in third-party costs
related to research services and manufacturing to advance our
current preclinical programs and Phase 1/2 clinical trial, as well
as a $2.5 million increase in personnel-related costs driven by an
increase in headcount and stock-based compensation.
For the three months ended June 30, 2022, general and
administrative expenses were $8.9 million, compared to $6.4 million
for the three months ended June 30, 2021. The increase was
primarily due to a $1.9 million increase in personnel-related costs
driven by an increase in headcount and stock-based compensation, a
$0.4 million increase in other miscellaneous expenses, a $0.1
million increase in legal fees, a $0.1 million increase in taxes, a
$0.1 million increase in occupancy expenses, and a $0.1 million
increase in insurance, offset by a $0.2 million decrease in
professional fees.
For the three months ended June 30, 2022, Nuvation Bio reported
a net loss of $34.9 million, or $0.16 per share. This compares to a
net loss of $19.3 million, or $0.09 per share, for the comparable
period in 2021.
On August 1, 2022, Nuvation Bio announced a restructuring,
including a 35% workforce reduction, to reduce operating costs and
align its organization with its re-prioritized development
programs.
About Nuvation Bio
Nuvation Bio is a biopharmaceutical company tackling some of the
greatest unmet needs in oncology by developing differentiated and
novel therapeutic candidates. Nuvation Bio's proprietary portfolio
includes mechanistically distinct oncology therapeutic product
candidates, each targeting some of the most difficult-to-treat
types of cancer. Nuvation Bio was founded in 2018 by biopharma
industry veteran David Hung, M.D., who previously founded
Medivation, Inc., which brought to patients one of the world's
leading prostate cancer medicines. Nuvation Bio has offices in New
York and San Francisco. For more information, please visit
www.nuvationbio.com.
Forward Looking Statements
Certain statements included in this press release that are not
historical facts are forward-looking statements for purposes of the
safe harbor provisions under the United States Private Securities
Litigation Reform Act of 1995. Forward-looking statements are
sometimes accompanied by words such as “believe,” “may,” “will,”
“estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,”
“would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,”
“outlook” and similar expressions that predict or indicate future
events or trends or that are not statements of historical matters.
These forward-looking statements include, but are not limited to,
statements regarding Nuvation Bio’s cash runway and the potential
therapeutic benefit of its product candidates. These statements are
based on various assumptions, whether or not identified in this
press release, and on the current expectations of the management
team of Nuvation Bio and are not predictions of actual performance.
These forward-looking statements are subject to a number of risks
and uncertainties that may cause actual results to differ from
those anticipated by the forward-looking statements, including but
not limited to the challenges associated with conducting drug
discovery and initiating or conducting clinical trials due to,
among other things, difficulties or delays in the regulatory
process, enrolling subjects or manufacturing or acquiring necessary
products; the emergence or worsening of adverse events or other
undesirable side effects; risks associated with preliminary and
interim data, which may not be representative of more mature data;
risks related to cost reduction efforts; and competitive
developments. Risks and uncertainties facing Nuvation Bio are
described more fully in its Form 10-Q to be filed with the SEC on
or about August 4, 2022, under the heading “Risk Factors,” and
other documents that Nuvation Bio has filed or will file with the
SEC. You are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the date of this
press release. Nuvation Bio disclaims any obligation or undertaking
to update, supplement or revise any forward-looking statements
contained in this press release.
NUVATION BIO INC. and Subsidiaries
Consolidated Balance Sheets Unaudited
(In thousands, except share and
per share data)
June 30, December 31,
2022
2021
Assets
Current assets: Cash and cash
equivalents
$
102,321
$
132,423
Prepaid expenses and other current assets
7,799
3,642
Marketable securities
601,476
632,969
Interest receivable on marketable securities
2,668
3,039
Total current assets
714,264
772,073
Property and equipment, net
894
786
Operating lease right-of-use assets
4,442
2,871
Lease security deposit
138
421
Total assets
$
719,738
$
776,151
Liabilities and stockholders'
equity Current liabilities:
Accounts payable
$
12,728
$
3,925
Current operating lease liabilities
941
863
Accrued expenses
7,605
12,137
Total current liabilities
21,274
16,925
Warrant liability
1,633
11,037
Non-current operating lease liabilities
3,752
2,192
Total liabilities
26,659
30,154
Stockholders' equity
Class A and Class B common stock and additional
paid in capital, $0.0001 par value per share; 1,060,000,000
(Class A 1,000,000,000, Class B
60,000,000) shares authorized as of June 30, 2022 and December 31,
2021, 218,244,300 (Class A
217,244,300, Class B 1,000,000) and 217,948,568 (Class A
216,948,568, Class B 1,000,000)
shares issued and outstanding as of June 30, 2022 and
December 31, 2021, respectively
919,011
909,985
Accumulated deficit
(218,954
)
(162,803
)
Accumulated other comprehensive income
(6,978
)
(1,185
)
Total stockholders' equity
693,079
745,997
Total liabilities and stockholders' equity
$
719,738
$
776,151
NUVATION BIO INC. and
Subsidiaries
Consolidated Statements of Operations and Comprehensive Loss
(In
thousands, except per share data)
Three Months Ended
June 30, Six Months Ended June 30,
2022
2021
2022
2021
Operating expenses:
Research and
development
$
28,922
$
14,034
$
49,650
$
29,913
General and administrative
8,948
6,400
16,411
11,005
Total operating expenses
37,870
20,434
66,061
40,918
Loss
from operations
(37,870
)
(20,434
)
(66,061
)
(40,918
)
Other
income (expense):
Interest income
841
776
1,798
1,214
Investment advisory fees
(215
)
(176
)
(384
)
(284
)
Change in fair value of warrant liability
3,080
500
9,404
207
Realized (loss) gain on marketable securities
(694
)
1
(908
)
46
Total other (expense) income, net
3,012
1,101
9,910
1,183
Loss
before income taxes
(34,858
)
(19,333
)
(56,151
)
(39,735
)
Provision
for income taxes
-
-
-
-
Net
loss
$
(34,858
)
$
(19,333
)
$
(56,151
)
$
(39,735
)
Net loss attributable to common stockholders
Net loss per share attributable
to common stockholders, basic and diluted
$
(0.16
)
$
(0.09
)
$
(0.26
)
$
(0.21
)
Weighted average common shares outstanding, basic and diluted
216,603
204,017
215,016
186,933
Comprehensive loss:
Net loss
$
(34,858
)
$
(19,333
)
$
(56,151
)
$
(39,735
)
Other comprehensive income, net of taxes:
Unrealized loss on available-for-sale
securities
(761
)
(224
)
(5,793
)
(800
)
Comprehensive loss
$
(35,619
)
$
(19,557
)
$
(61,944
)
$
(40,535
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220804005636/en/
Nuvation Bio Investors: ir@nuvationbio.com
Nuvation Bio Media: Argot Partners Leo Vartorella
leo@argotpartners.com
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